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Pain Relief PM (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. TOP CARE (Topco Associates LLC)

Generic: acetaminophen, diphenhydramine hcl

Pain Relief PM tablet - (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) image

IMPRINT: S525 V15 AV CPC 752     SHAPE: capsule
    COLOR: blue

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose


Pain reliever

Nighttime sleep aid

Uses


Temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 2 caplets in 24 hours, which is maximum daily amount 
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with other products containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

If pregnant or breast-feeding,


ask a health care professional before use.

Keep out of reach of children.


Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
 
adults and children 12 years and over
  
  • take 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours
 
children under 12 years
  
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • store at room temperature 15o- 30o C (59o- 86o F), avoid high humidity and excessive heat

Inactive Ingredients


colloidal silicon dioxide*, croscarmellose sodium*, D&C Yellow #10 Aluminum Lake*, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol, polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

*contains one or more of these ingredients

Questions Or Comments?


Call toll free 1-888-423-0139

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Compare to TYLENOL® PM active ingredients**

extra strength

Non Habit forming

Pain Relief PM

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

Pain reliever/ Nighttime Sleep Aid

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM

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Product Label


Pain Relief PM Caplets  

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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